Zack Struver's blog

Kite Pharma is a California-based biopharmaceutical company working on various types of cell therapies for the treatment of cancer, in a bid to become the first pharmaceutical firm to gain successful FDA approval for this new class of cancer treatment.

Kite closely collaborates with the National Cancer Institute, which conducted significant early research into the forms of cell therapies that Kite is seeking to commercialize. NCI conducts clinical trials under Cooperative Research and Development Agreements (CRADAs) with Kite, and additionally has granted exclusive licenses on over a dozen patents to Kite on the same technologies.

Kite Pharma, Inc., which is racing Juno Therapeutics and Swiss pharmaceutical giant Novartis to successfully bring the first T-cell receptor (TCR) therapy to market, relies heavily on government support in the course of its research and development.

As noted previously by KEI, in various comments to the National Institutes of Health, the NIH rarely discloses detailed information on its connections with industry, raising concerns about how the NIH licenses out taxpayer-funded technologies without regard for future prices or access for U.S. residents.

T-cell receptor therapy is the latest breakthrough in cancer treatment, and involves modifying a patient's own cells to better track and destroy cancer proteins, and then reintroducing them into the body. (The NIH has a concise description for non-scientists here.)

Dr. Steven A. Rosenberg is the Principal Investigator for the National Cancer Institute on Kite's 2012 CRADA. Dr. Rosenberg mentored Kite CEO and co-Founder Dr. Arie Belldegrun, and is also listed as a "Special Advisor" to Kite on their website. | Partnership for Public Service / Aaron Clamage

According to Kite’s filings with the Securities and Exchange Commission (SEC), Kite has secured three Cooperative Research and Development Agreements (CRADAs) with the National Cancer Institute (NCI). In exchange for quarterly cash payments, the NCI conducts clinical trials and laboratory work on many of its own patented technologies, with the understanding that Kite will have the rights to commercialize any successful products developed through the CRADA.

Washington, DC — Today, over 50 patient, senior citizen, global health, development, social justice, and faith groups urged the United States Government to use its rights in a federally funded patented invention, and accept the request by a Canadian generic drug manufacturer (Biolyse Pharma) to enter into an agreement to manufacture and export an affordable version of the taxpayer-funded prostate cancer drug enzalutamide to South Africa and other countries with low per-capita incomes relative to the United States.

Knowledge Ecology International recently obtained extensive email correspondence between officials at the National Institutes of Health (NIH), the Foundation for the National Institutes of Health (FNIH), and the National Football League (NFL), which shed light on accusations of NFL attempts to control the NIH research agenda related to repeat concussion injuries in football players.

The National Institutes of Health, from 2011 through May of 2015, appears to have granted all requests for waivers of a requirement under federal law that patent holders who benefit from U.S. taxpayer-funding ensure that their patented inventions are manufactured in the United States.

The Bayh-Dole Act imposes various requirements on the grant of exclusive licenses by the patent holders of federally-funded inventions. In particular, the act generally requires that exclusive licensees “substantially” manufacture the invention in the United States.

The Act, however, also allows for the patent holder to obtain a waiver on the U.S. manufacturing requirement from the Federal agency that provided for the funding of the invention. According to a FOIA response recently obtained by Knowledge Ecology International, the NIH seems to grant every manufacturing waiver request that comes its way.

On September 14, 2016, the United Nations Secretary-General’s High-Level Panel on Access to Medicines released its report, in which they had a mandate to “review and assess proposals and recommend solutions for remedying the policy incoherence between the justifiable rights of inventors, international human rights law, trade rules and public health in the context of health technologies.”[1]

The attached briefing note analyzes transparency legislation that has been proposed in 14 states in 2015 and 2016. The bills would require various degrees of transparency for research and development (R&D) and marketing costs, as well as for drug prices and price changes.

Bloomberg reported on August 2, 2016, that CVS Health announced that it plans to exclude 35 drugs from its formulary beginning in 2017, including Xtandi, bringing the total number of excluded drugs to 131.

Evidence shows pattern of interference in national and international efforts to improve access to affordable medicines, according to Doctors Without Borders (MSF USA), Knowledge Ecology International, Public Citizen, Oxfam, and other leading public interest groups.

Washington, DC — More than 50 public interest organizations and experts asked Secretary of State John Kerry today to explain evidence that the State Department recently pressured the United Nations and the governments of Colombia and India against taking action to improve access to affordable medicines, citing U.S. business interests and implying that relations with Washington would suffer.

KEI will host a conference call at 11:00 A.M. today to brief interested stakeholders and the press on issues related to NIH patent policy, including the recent decision in KEI's Xtandi petition (additional background here: http://keionline.org/xtandi), the grant of exclusive licenses on government-owned inventions (http://keionline.org/nih-licenses), and transparency of decision-making at NIH more broadly.

Dr. S. Ward Casscells took the stage at the 2011 Innovative Minds in Prostate Cancer Today (IMPaCT) Meeting as a prostate cancer patient, a doctor, an Army Reserve colonel, and the former top doctor for the Pentagon. There, he praised the central role of the Department of Defense in bringing important prostate cancer medicines to market, including Xtandi (referred to by its experimental name, MDV3100), an expensive prostate cancer drug that was funded from basic research through phase I and II clinical trials by taxpayer and charitable funds.

Washington, DC — Today, 28 organizations that support the advancement of public health, as well as the successful continuation of the peace process in Colombia, urged President Obama to voice U.S. support for Colombia’s right to grant a compulsory license on an expensive leukemia drug.

Before the U.S. Senate Committee on Health, Education, Labor and Pensions (HELP) presents a legislative package of healthcare reforms to the Senate floor for an up-or-down vote, 13 consumer, patient and health non-profit groups sent a letter to HELP Chairman and Ranking Member to ensure that the final legislative package includes only those bills that the HELP Committee reviewed in mark-up sessions.